N/A
N=45
Adjuvant Doxorubicin/Cyclophosphamide and Paclitaxel Plus Sorafenib Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00544167 ↗Enrolled (actual)
45
Serious AEs
15.6%
Results posted
Jan 2013
Primary outcome: Primary: The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0. — 40 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Doxorubicin (Drug); Cyclophosphamide (Drug); Paclitaxel (Drug); Sorafenib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0. |
40 | — |
Summary
Sorafenib is being looked at in a number of solid tumor settings including breast cancer. This trial is designed as a pilot study to assess the safety and tolerability of a novel oral agent in combination with standard chemotherapy in the treatment of early stage node positive or otherwise high-risk breast cancer. If this should prove to be a tolerable regimen for patients, this would provide rationale for further studies in a larger randomized fashion.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically-confirmed breast cancer with an interval between definitive surgery that includes axillary lymph node involvement assessment and initiation of study treatment of less than or equal to 84 days.
- Definitive surgery - either mastectomy with axillary node involvement assessment, or breast conserving surgery with axillary node assessment. Margins of resected specimen must be free of invasive disease and/or ductal carcinoma in situ (DCIS).
- Stage I, II, IIIA, and IIIC (T1-3, N3a only). Patients must be either lymph node positive or high-risk node negative.
- Age > 18 years.
- ECOG performance status 0 or 1.
- Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) by Echocardiography or MUGA scan and electrocardiogram (ECG) within 35 days prior to initiation of study treatment.
- Patients must have adequate bone marrow function
- Patients must have normal liver function (
- Serum creatinine 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications); patients who receive medications for angina, arrhythmias, or congestive heart failure.
- Current therapy with raloxifene, tamoxifen or other selective estrogen receptor modulator
- Concurrent treatment with ovarian hormonal replacement therapy.
- History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.
- Women who are pregnant (positive pregnancy test) or breast feeding. Subjects of childbearing potential must use effective birth control measures during treatment.
- Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
- Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Thrombotic or embolic events such as a stroke and transient ischemic attack within the past 6 months.
- Pulmonary hemorrhage/bleeding event ≥ NCI CTCAE v3.0 Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event ≥ NCI CTCAE v3.0 Grade 3 within 4 weeks of first dose of study drug.
Data sourced from ClinicalTrials.gov (NCT00544167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.